Pfizer’s sterile injectable facility in Portage, Kalamazoo is among the sites being leveraged to support clinical trials of a COVID-19 vaccine being developed with BioNTech. In April, Pfizer teamed up with German firm BioNTech on its messenger (RNA) vaccine program against COVID-19, caused by the novel coronavirus (SARS-CoV-2). A month on, and the candidate BNT162 has entered the clinic with the first US patients being dosed in a Phase I/II trial this week. To support rapid development, Pfizer has stressed…

Catalent will make scaled-up batches of Arcturus Therapeutics’ mRNA vaccine candidate from a customized suite at its Madison, Wisconsin facility. The CDMO says it has been presented with around 100 opportunities to support COVID-19 development projects. Under terms of the deal, financials of which have not been divulged, contract development and manufacturing organization (CDMO) Catalent will make Arcturus’ COVID-19 messenger RNA (mRNA) vaccine candidate LUNAR-COV19 to support clinical trials. The potential single-shot vaccine uses Arcturus’ STARR Technology platform, which combines…

Biogen says construction of its manufacturing site in Switzerland is complete and will produce commercial supply of aducanumab if the potential Alzheimer’s blockbuster is approved. Biogen has had a turbulent time with its proposed Alzheimer’s disease monoclonal antibody aducanumab. In 2015, data was announced that led the company to outline a Phase III study. Then in March 2019, late-stage results prompted Biogen to shelve the drug. Months later, the firm resurrected the program, after “new analysis of a larger dataset”…

Lonza will begin producing batches of mRNA-1273 from its site in New Hampshire in July as Moderna looks to achieve its goal of one billion doses of the potential COVID-19 vaccine annually. Moderna Therapeutics’ mRNA-1273 is one of the frontrunners in the race to develop a vaccine against the coronavirus (SARS-CoV-2). The messenger RNA (mRNA)-based candidate entered Phase I clinical trials in March, and last week Moderna submitted an Investigational New Drug (IND) application for Phase II and late-stage studies.…

There are 94 COVID-19 vaccines in development but almost no capacity to produce them at meaningful scale says Sanofi, which is aiming to go from 100 million doses of a recombinant protein candidate to a billion in 12 months. Industry’s response to coronavirus (SARS-CoV-2) has been, to use the word of the moment, unprecedented. Scores of COVID-19 vaccines are in various stages of development. Sanofi is involved in two vaccine programs, representing a “huge opportunity for our organization,” CEO Paul…